RightFit
RecruitingPhase 1 / Phase 2

Nicotinic Acid for the Treatment of Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills, Heart tracing (ECG), Blood draws, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The control/placebo group will use microcrystalline cellulose tablets."
  • "The size and shape of the placebo pill will be chosen to most closely match the other treatment tablets."
  • "At the 30-day visit a pill count will be undertaken to reinforce compliance."
  • "The bottle and any remaining pills will be collected at the end of the study and compliance will be assessed."
  • "All pill counts and pill instructions will be given by a separate study coordinator (due to inability to have a perfectly matching placebo) so that primary study coordinator and principal investigator remain blinded throughout the study."
  • "Pill count is completed at the interim visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how much of a 500 mg dose of slow-release niacin (vitamin B3) reaches the blood and fluid around the brain and spinal cord. It compares niacin with a placebo and checks its safety and side effects. It is for adults ages 60–85 with mild to moderate Alzheimer's dementia.

Increased dietary intake of niacin is correlated with reduced risk of Alzheimer's Disease and age-associated cognitive decline. The goal of this study is to collect data on the penetration of commercially available, FDA approved, extended-release niacin into the spinal fluid. One dose of 500 mg nicotinic acid will be used (in addition to placebo) to build a dose response curve for this compound in human cerebrospinal fluid. This objective will demonstrate target engagement of HCAR2 in the central nervous system, after oral treatment with niacin. The primary endpoints are to show increased nicotinic acid levels in blood and cerebrospinal fluid. A secondary endpoint is to collect safety and tolerability data of niacin in this particular population.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 60–85 years old.
  • Have mild to moderate Alzheimer's dementia, with a score of 14–24 on the Mini Mental Status Examination (a memory and thinking test).
  • For at least 30 days, have had no change in your dose of Alzheimer's medicines called cholinesterase inhibitors or memantine, or in not taking them.
  • Have a reliable study partner who sees you in person at least 3 days a week and makes sure you take the study drug as directed.
  • Have a brain MRI or CT scan available from within 1 year before screening.

Who can't join

  • Cannot safely have a spinal tap (a test that takes spinal fluid). Reasons include high pressure inside the skull, a mass at the back of the brain, a bleeding disorder, or use of blood thinners or medicines that stop blood cells from clumping, other than aspirin.
  • Have severe disease of the brain's blood vessels.
  • Have had a stroke affecting a large area of the brain.
  • Have an allergy or sensitivity to B vitamins or niacin.
  • Have known liver disease or past liver blood test results (ALT or AST) more than twice the upper limit of normal.
  • Currently take vitamin B3 in any form, including in multivitamins or energy drinks. You must stop supplements containing niacin for 4 weeks before screening.
  • Have stage 2 or worse kidney problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Age 60-85 males or females Clinically have a diagnosis of Alzheimer's disease in the mild-moderate dementia range Mini Mental Status Examination (MMSE) between 14-24 inclusive Must be on a stable dose (30 days minimum) of a cholinesterase inhibitor and/or memantine (or absence thereof) Have a reliable co-participant who has at least 3 days of face-to-face contact per week with the patient and ensures medical compliance with the study drug. Neuroimaging (MRI or CT scan of the brain) should be available within 1 year of screening Exclusion Criteria: Any contraindication to clinical lumbar puncture including increased intracranial pressure, posterior fossa mass, bleeding diathesis, use of antiplatelet medications other than aspirin, use of any anticoagulant Severe cerebrovascular disease History of large territory stroke Allergy or sensitivity to B-vitamins or nicotinic acid History of elevated liver function tests (ALT/AST \> 2x the upper limit of normal) or known liver disease Current consumption of Vitamin B3 (any form, including nicotinic acid) - including multivitamins and energy drinks. Participants taking a supplement containing Niacin must washout for 4 weeks prior to screening to participate. Renal impairment of Stage 2 or greater

Study sites (1)

IN